Granules India today said the US Food and Drug Administration has approved its Abbreviated New Drug Application ((ANDA) filed by USpharma Windlas LLC for Prasugrel tablets, used for treatment of heart disease.
According to a statement issued by Granules, it has an exclusive tie up with USpharma to market and distribute four drugs of the latter, including Prasugrel (5 mg and 10 mg).
Prasugrel is indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome.
"The approved ANDA is the bio-equivalent to the reference listed drug product (RLD) Effient tablets 5 mg and 10 mg of Eli Lilly and Company, the release said.
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